Rune's picture
Doctor.. could you hack me a neuroprosthesis, please?

The Challenge: 

The Question: 

How can we make novel assitive technology available to people living with physical disabilities

The Problem: 

Several results of applied research does not benefit the user of the healthcare system

The Solution: 

Creation of a makerspace for coworking between patients, researchers and healthcare professionals

Channels: 

Doctor.. could you hack me a neuroprosthesis, please?

(The thoughts expressed here are a personal view and do not reflect the opinion of former or current employers)

When I was a little boy, in 1973, Bob Marley was singing Get Up, Stand up for your rights and the article "Functional electrical stimulation - A new hope for paraplegic patients?" was published. Now, 40 year on, as a senior researcher in rehabilitation engineering I look back on things that are still true: people still fight and patients still hope. Can we improve life conditions, and how? A fundamental question is: do we meet the ‘clients’ needs?

Just to give an example:  My mother suffered from a slipped disc so passing the vacuum cleaner was a low back pain for her. As a good boy I stated: "When I grow up mom, I’ll invent a cleaning robot to do the job for you". Someone beat me to it - the cleaning robot is a reality - it sells well, and substitutes the socializing cleaning woman once offered to the elderly. I see now that a cleaning robot is not what a mother really wants. She just wants a good boy saying: “mom, I'll do that part of the cleaning with you”, and do it right away.

Until doing my masters, the disabled people were an unknown phenomenon to me. They were not seen, not talked about. I was introduced to young people suddenly wheelchair bound with very limited personal independence due to a spinal cord injury.  They were really nice people and kindly explained about the complexity of such sudden change in abilities and about the need to regain some functional movements.

First of all they told me where my ideas were no good and what research needed to be done. Together we coined a method, not an ambitious cure, just a simple idea that could help a bit and during my Ph.D dissertation, we demonstrated feasibility of restoring the hand function using electrical activation of the paralysed muscles. Not a fits all solution and not perfect, but as people say: when you have nothing, a little is a lot, and for some people it works well (see the video)

We still research in restoration of walking in paraplegic patients and quite a few assistive devices have been marketed (braces, functional electrical stimulation and robots ).

I have been active in the field for 20 years working at major rehabilitation institutions, but I’ve only rarely seen patients being offered these assistive technologies and more rarely seen them  used outside the hospital. Is the problem (as some people with SCI have entrusted me) that there is no such demand or ‘new hope’ for walking? After all, wheels are more efficient than legs - provided accessibility!!!

Another hypothesis could be an issue of lack of flexibility of the healthcare system, not beeing able to provide state of the art technology to patients !?

Still, for more than forty years we continue producing scientific publications with conclusions like: “…the work carried out so far proves that functional movements can be restored...We therefore believe that patients can benefit. Further research should be carried out”.

Please, don’t get me wrong. The research contribute with important results, but obviously there is a problem of transferring the research results into the benefit of people with physical challenges.

So far business oriented people responds that it’s because the solutions are not technically good enough, that they only fit a few thousand patients and we continue the research for enhancements to the technology and demonstrate clinically effectiveness.

On the other hand less ambitious solutions have been available since the 60’ties, to alleviate the simple problem of foot drop. It applies to thousands of people living with stroke, multiple sclerosis or spinal cord injury. It’s a little electrical device providing electrical impulses to the muscle that lifts the foot and I’ve encountered many people with stroke and multiple sclerosis who gained significantly in mobility (see this user statement).

Despite demonstrated clinical efficiency and the immediate advantages it’s almost never proposed to the patients of the health care system (except for the UK [11]). Why???

So on the one hand we spend million dollar research to refine technology that is not widely used!!!!. Will our institutions and society implement the provision of such technology!?

They need one solution that fits many, because the modern health care model reduce human life in cost/benefit analysis to numbers. However, as long as assistive technology is not used it’s difficult to identify exactly where to improve it.  We know that consumers must be involved early in the development, it’s difficult to do so in a realistic setting. We realize that marketing assistive technology is different than selling a robot vacuum cleaner.

So a relatively simple method of restoring the hand function in people having broken their neck (cervical spinal cord injury), that has been demonstrated useful in a large clinical trial has not become available to people who really need it because it does not fit the ‘business model’  of modern health care systems !?

As an example we experienced that half the participants wanted to take the experimental device with them home. We are not allowed to do that. I’ve only spend around 50 euro to build the prototype in the laboratory, but we are not in the 1970’ies anymore. In the name of assuring ‘quality’, ‘safety’ etc,  we need to manufacture, CE mark, register as a medical device and so on!.  To provide a patient with a medical device we need to spend hundreds of thousands of euros on paperwork!!! And who is then going to sell at a reasonable price.  Why should people, already challenged economically by loss of health, spend 5-10 k€  for a device that could be made much cheaper?

That’s where the revolution of OpenCare –with a subset of community driven provision of assistive technology - comes in.

Could we leave people with a physical handicap to become a maker, create their own assistive technology?

Would it be possible for, for example, researchers to help people living with a disability to hack a dropped foot correcting device like connecting an Arduino with an extension board?

Will doctors provide indications of how to find the assistive technology, which might solve your health issue?

That would mean that people should take responsibility for their own rehabilitation devices. They would have full ownership. Clearly they must be guided by healthcare professionals and experts without conflict of interests to ensure that everything is done ethically, safe and sound. How?

Maybe if we reunite people living with physical challenges with researchers they would both benefit and research becomes action and functionally useful to the society?

What do you think?

July 2016                    Rune Thorsen               

Comments

Whoa. What about patients associations?

Noemi's picture

Very insightful piece,  thanks Rune. When writing OpenCare we were inspired by the story of a visually impaired person in Milano building his own self standing cane as an everyday support for various tasks requiring both operative hands. He did this in a makerspace. @Costantino, are you guys at WeMake seeing collaboration with researchers in similar cases? Or are there events which can aid that? 

Reading carefully the above,  there's one thing that strikes me: how come patients associations don't lobby for provision of assisting technology outside the formalised hospital care? Isn't this the kind of thing that they would be best at, being on the *organised* patient and consumer side? 

Organizations

Rune's picture

Good point on the organizations @Noemi. I have several times been trying to involve associations with little luck. They are very interessted, but the buck stops there. Maybe they are too busy surviving, maybe they are too focused on initial goals, maybe,,,, It's clear that they don't have resources to follow and digest current research and therefore are unaware. Maybe they are drowning in information about mainstream research (e.g. stem cells). Maybe you know?

Regarding @Costantino, I have been airing the idea of making a 'neuroprostethics' hacking event. We need the right subject (patient), a clinician (OpenCare type) and clear some formal issues. Some people that I had in mind had to drop out (for logistic and health problems). 

In this hacking event we will help a person to create his/her neuroprosthesis to recover hand or foot function. This could be a kickoff workshop for a project the we call WeHandU - a hackerspace for people with spinal cord injury,stroke, multiple sclerosis. It fits perfectly to a 100k grant coming up in september, but we need to recruit paricipants before time runs out.

Like that

Alberto's picture

Good piece! It seems you are saying that, while pathology might lend themselves to classifications, patients are all different (@markomanka always says this). My diabetes is different from yours, because you are not overweight and I am, etc. This calls for small batch solutions rather than cookie-cutter solutions. Makers are efficient at small batch, industry is efficient at cookie-cutter. So, for health care, it should be makers. 

It should not be so difficult to set up something like a voucher system for disabled people. You've got a condition? Here's your voucher, head off to your local makerspace, someone will talk to you. There's a condition, though: you'll need to be an active participant, not a passive consumer. You'll need to help with design, testing, providing feedback. In other words, you will need to join a community of makers. Your exact role will depend on your skillset and enthusiasm: the harder you work, the better the outcome solution will fit your particular condition. 

Right?

Barter economy

Rune's picture

Head on  Alberto. How can this voucher be implemented in an efficient way. Are there some tools?

Our proposal is that it should be an 'association' of participants (the patients), mentors (patients who done it) and facilitators (e.g. us-researchers, clinicians, etc....)

Participants come and see if WeHandU has a solution  that solves the problem. If yes, then they becomes associates with a moral obligation to become mentors (helping newbees). This part should be free. Eventually facilitators time has to be payed in some way (It's probably impossible to convince a professional therapist to work for free)

Are there some projects we can learn from?

I hope Eirini reads this

Noemi's picture

It just occured to me that @eirinimal could be interested in this piece on resistance to cheap hitech assistive devices. Did your company get to work in the medical system per se or are you mostly marketing outside of it?

I would like to start from the bottom...

markomanka's picture

​Thank you @Nadia for pointing this out :)

This is an interesting post, touching on a number of open questions, some receiving partial implicit answers in the same text, others remaining open at all.

I would like to start from the bottom of it. Transforming patients (or their closest carers) into makers is an interesting perspective. We know from citizen science that this first hands involvement often offers a stimulus to personal studies, and reflection about the identity of the problem, and the problem holder. One could argue this is an even more important potential benefit than the access to the devices in itself.

However, an important reflection should happen about quality and safety. If one cannot bring a simple solution to the market because of the iters for safety and quality certification, and this we agree is bad, the solution should not be "ok, let's ignore this step and bypass it".
There are a number of issues here. 1st and foremost, one has to describe how safety and quality are reasonably assured, and what safety net would be put in place should something still happen (although we know they are not perfect, to use an euphemism, today a number of tools and services exist to cover for assistance, accidents' costs, etc on the side of providers).
Of course, one could ignore this. Depending on the IP scheme, no safety nets would be needed (although it would nice to think of them), for example. But this brings us to a second issue, one that is almost "ethical": transforming every patient in a maker can leverage the citizen-scientist effect only if (this is presented as gut feeling here, but I am open to discuss it in depth later) the right IP scheme is adopted. And only if radical openness is adopted one can truly claim no responsibility over the final "accidents" that will always happen (only that which does not work, will not break). Should the creator preserve control of the IP for itself, one will always find a court that will consider the business model "exploitative", and enforce the order to establish the aforementioned safety nets (there is an interesting case about a fire happend in an AirBnB apartment that touches on this topic)... falling back to the problem one wanted to work around, just a bit later.
So, what would be the general ecosystem' services that would keep this garden grow orderly? I don't see this answered (that's not an easy one, indeed)
Research, and "citizen science", target the pioneers and early adopters... To scale beyond that, we need to think the entire ecosystem, and be humble.

For the sake of our understanding, let me be pedant and allow me to stress that disabilities do not exist in silos. People have many things going on in their lives, and around them, of course also the disabled ones. They do not stop living when they change status. A few will want to pioneer, some will want to have new solutions, some others will not want any because... I am not sure they need a "because".

I would like to not dig too deep in the question about why the current "solutions" are often not marketed/offered... just for the sake of reasoning together: if you had a clue about how to build an engine, and it would work once every 100 attempts after serious tinkering... would you be able to market it? Let's be honest with ourselves and remember that researchers are very optimistic people (I belong to the category, so this is self-criticism). They will produce proof of concepts, hardly ever demonstrators (although they usually confuse the terminology), and they don't normally ask themselves questions like "how long will this work continuously?", "what will be the safety mechanism once it turns off, as instance because of battery exhaustion?", how many scenarios are realistically recapitulated in the lab I used for the tests, and how well does this solution generalize?",...
Let's not dive in the argument of healthcare provision on this topic. Sometimes it is the right reflection to face, some other it is populistic... In these circumstances it reminds of the sentence I have recently read on twitter "being poor means having too much end of the month"... it may steal a smile, but it's a classic example of ill-posedness. You will not solve poverty by trying to shorten the calendar.




 

How much access is real access than?

Noemi's picture

Thanks Marco, many money quotes in your comment !!

My understanding of Rune's post is that research admittedly needs to be refined ("as long as assistive technology is not used it’s difficult to identify exactly where to improve it") in ways that are more just to the users than current commercial research and the incentives that exist in that space. Since research lab + home brewed medical inventions and tools exist already and provide healthy tinkering and reflection around problems, then the easier question is then how to enlarge access to this kind of knowledge, enable more people to be players. More access could mean better quality and approach to safeguards, and then markets (should) follow. Hopefully before research and money go down the drain or results made irrelevant.

Response to Marco

Rune's picture

Thanks @Noemi for helping me out on responding @markomanka.

I'll try to go through the points 

* The transformation of cronic patients into makers is scientifically documented. Something like 50% of patients have been creating an innovative solution for their health problem (SocialMediaWeek Milan 2016) but, either I don’t understand what you mean by ‚stimulus to personal studies’ or I strongly disagree. Production of the device should simply be a joyful and possibly a beneficial process. Avoiding personal defeat is ethical top priority.

* Lets make it clear: Quality is one thing, safety is another. Quality depends on the maker = participant. Safety is ensured by facilitator and mentors. Safety is a relative issue. Walking is risky – you may fall, therefore the neurologist may advice stop walking and use a wheelchair instead (a real casestory). As when we do clinical trials, the participant must be guided through a ‚risk assessment’

* What you say about ‚bypassing’ is actually the reason for hacking - for opencare. Once you certify your product is ‚frozen’. Yes it’s about bypassing >100k euro of CE marking expenses of a product which the user has to pay (https://edgeryders.eu/en/fes-for-foot-drop). You can't meet individual requirements because youll lose certification.

However you have a point. Help us to find a way to ennsure that this is legal and how participants can be ensured in case of accidents. Please?

* don't get your point about IP!???? We are in open context, free,

* Responsibility and lawsuits. I can see you are a lawyer mind so please help out on this point? (Yes the idea is that the paricipant is fully responsible) How does the makerspaces go about this issue (@Costantino)?

‚Disabled ones’ are in this case people, the participants, looking for a alleviation for lack of body function. In contrast to established health care ( were the patient is often a passive receiver patiently waiting for ....), the WeHandU (see above reply) philosophy is NOT to decide what is best for a patient. Rather a person living with an impairment is looking for a way to resolve that HE/SHE considers a problem and hopefully resolve/alleviate it in a creative environment (I am often contacted by such people). The ‚not-patient’ but participant is... a participant. People not ‚wanting any aid’ (and they are most) will not come in WeHandU. (BTW. Disabled people is not existing in the modern vocabulary)

* Solutions not marketed is a complex one. As graduate student I believed (was taught) that if it works it will be sold. That’s not the way of business. Healthcare is business. Hard cold  business. A businees where 90%  of the healthcare budget is spend on a solution that does not work. 90% (EU data) is spend on treating cronic diseases. Why are they cronic? Because the cure we are paying is not working... ok I’m being cheeky here ;-)   

If you study the dropped foot stimulators, invented 50 years ago, there is a ton of scientific work that demonstrates efficiency. Its provided by NHS in england, but not in the rest of europe. Why?

* Optimistic research. No, rather pragmatic - If something does not work try something different. The different is to eliminate the last variable (confounder is the term) not yet controlled in 50years of research: FAILING INSTITUTIONS (article on edgeryders).

What would you suggest as a cut off for a clinically relevant change?

How many people regaining some hand function? How many people walking yet some years before they end in a wheelchair? Would 10 suffice or do we need 100.mio (A cervical spinal cord injury cost society approx. 1mio$/year) 

What if one of them was you? Would the existence of WeHandU space be justified it it could preserve you some personal independence?

We have a choice here: continue spending millions on research refining (reinventing) technology (http://www.eurekalert.org/pub_releases/2016-01/kf-kfa010716.php). Promising technology that has not been marketed or clinically relevant for many years?

H0: We can demonstrate that it is useless by testing the last hypothesis (which is that OpenCare approach can solve the ‚marketing’ problem).

What do you propose?

Legal issues

Rune's picture

What @markomanca says about safety and legal issues is important and needs some opencare attention. I've started this section in the invitation letter (it's not the right place but my best shot)

https://docs.google.com/document/d/1NKc2bM1FnpQ9zCEveieFr7bIGA9JkI8U_adsBpyma1A/edit#heading=h.5obrk7n45hk3

Maybe you could elaborate?

 

Implementation

Rune's picture

WeMake will back it

Costantino's picture

So, the conversation with @Rune is going on since some time now. 

As WeMake I'm pretty conviced to back this project in the opencare realm. 

We're in the process of understanding the possible implementations but we're totally in.

@marcomanca I think that many of the issues discussed above should be digged more during the workshop @cern :) 

 

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